Standard Operating Procedure for Stability Testing of Lyophilized Products
1) Purpose
This SOP outlines the procedure for conducting stability testing on lyophilized products to ensure their long-term viability, potency, and safety throughout the product’s shelf life.
2) Scope
This SOP applies to all personnel responsible for conducting stability testing of lyophilized products, including formulation scientists, laboratory technicians, and QA personnel.
3) Responsibilities
- Formulation Scientists: Responsible for developing the stability testing protocol and ensuring that the testing parameters reflect the product’s storage conditions and intended use.
- Laboratory Technicians: Responsible for conducting stability testing at designated time points and accurately recording the results.
- QA Personnel: Responsible for reviewing and verifying the stability testing data.
4) Procedure
4.1 Stability Testing Protocol
4.1.1 Selection of Testing Conditions
- 4.1.1.1 Select stability testing conditions that reflect real-time and accelerated aging conditions, such as storage at 2-8°C, room temperature, and elevated temperatures (e.g., 40°C).
4.1.2 Testing Schedule
- 4.1.2.1 Perform stability testing at predefined intervals (e.g., 0, 1, 3, 6, 9, 12, and 24 months) to monitor product degradation over time.
4.2 Stability Testing Parameters
4.2.1 Visual Inspection
- 4.2.1.1 Inspect the lyophilized product for color changes, caking, or other visible signs of degradation.
4.2.2 Potency and Purity Testing
- 4.2.2.1 Conduct potency assays to measure the active ingredient’s efficacy
over time. Additionally, perform purity tests to detect any degradation products.
4.2.3 Moisture Content
- 4.2.3.1 Use analytical techniques such as Karl Fischer titration to measure the residual moisture content and ensure it remains within acceptable limits throughout storage.
4.3 Documentation
Record all stability testing results in the Stability Testing Logbook, including visual observations, potency, purity, and moisture content data. Ensure that all records are signed off by both the laboratory technician and QA personnel.
5) Abbreviations
- QA: Quality Assurance
6) Documents
- Stability Testing Logbook
7) References
- Pharmacopoeial guidelines for stability testing of pharmaceutical products
8) SOP Version
Version 1.0
Annexure
Stability Testing Logbook Template
| Date | Product Name | Batch No. | Testing Results | Temperature and Storage Conditions | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Product Name | Batch Number | Pass/Fail | Conditions | Operator Name | QA Initials |